Hematology analyzers recalled because saturation flags may not be applied
Abbott Laboratories is recalling 833 Alinity hq Analyzers because a software issue means the system does not visibly flag results when saturation is present, which may give incorrect results.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: results that should be flagged as suspect can be reported as valid, and no injuries are reported.
Plain-English summary
The Abbott Alinity hq Analyzer, model 09P68-01, is being recalled across software versions 5.0 to 5.10.1 outside the United States and 5.7 and 5.10.1 in the United States.
A software issue for the hq analyzer results in the system not visibly applying appropriate flagging to results when saturation is present, which may result in incorrect results.
The recall covers 833 units, distributed worldwide including in Alabama, California, Colorado, Florida, Indiana, Minnesota, North Carolina, New York and Oklahoma. The FDA has classified the action as Class II.
A missing flag means a result that should be treated as suspect can be reported as if it were valid. Laboratories running an affected version should follow Abbott's instructions.
The recalled product
- Product
- Brand Name: Alinity hq Analyzer Product Name: Alinity hq Analyzer Model/Catalog Number: 09P68-01 Software Version: 5.0 to 5.10.1 for OUS, 5.7 and 5.10.1 in the US Product Description: Alinity hq Analyzer Component: No
- Manufacturer
- Abbott Laboratories
- Affected units
- 833
Distribution
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